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      蒸汽滅菌器不銹鋼表面資訊(第一期)
      來源: | 作者:浙江脈諾 | 發布時間: 2023-07-10 | 19 次瀏覽 | 分享到:

      前言


        在加工醫療產品時,高質量絕對是至關重要的。德國無菌供應學會(DGSV e.V.)的目標是提高醫療產品加工的整體質量。實現這一質量改進的方法之一是提高工藝可靠性,這是我們的主要目標?;颊呤俏覀兯鲆磺械闹攸c。此外,實際的行業經驗也可以幫助提高質量。紅銹是蒸汽滅菌過程中一個眾所周知的質量問題。但是實際上是什么導致了紅銹的出現,操作人員如何消除這些原因并防止它們成為一個問題呢?在這本手冊中,你會發現對這個非常高質量的問題的描述,以及你可以采取的步驟來成功地解決這個問題本身和找到它的起因。


      Maik Roitsch

      DGSV主席

      Foreword


        When processing medical products, a high level of quality is absolutely critical. The mis- sion of the German Society of Sterile Sup- ply (DGSV e.V.) is to improve the overall quality of medical products processing. One of the ways to achieve this quality im- provement is by increasing process reliabi- lity, which is our primary objective. The patient is the focus of everything we do. In addition to this, actual industry experience can also help to improve quality. Rouging is a well known quality issue in the steam sterilization process. But what actually cau ses rouging, and how can operators elimi- nate these causes and prevent them from becoming a problem? In this brochure, you'll find a description of this very quality issue, as well as steps that you can take to successfully address both the issue itself and its causes.


      Maik Roitsch

      DGSV Chairman

      介 紹

      圖1:狀況良好的腔室的典型圖像

      圖2:重復使用后的腔室狀況(可見腔室變色)

      當醫療器械被再加工時,它們會在蒸汽消毒器中進行消毒,這是專門為手頭的任務而特別優化的。作為一種公認的觀念,蒸汽滅菌是一種研究充分、可靠的處理方法。在腔室的技術設計中,使用高合金奧氏體不銹鋼合金,如1.4301、1.4404、1.4571和其他類似合金作為結構材料。圖1和圖2顯示了一個典型的蒸汽消毒器的例子,可以看到快速滅菌柜的內部。


        在許多應用情況下,實際操作經驗顯示,在滅菌室的使用壽命中,滅菌室內部的不銹鋼拋光表面經常出現不希望的變色。這些所謂的抗銹不銹鋼表面的變化(見圖2)的變化往往使負責MPPU/CSSD(醫療產品處理單元/中央無菌服務部門)儀器運行的員工感到不安。
        本指南的目的是在某些情況下深入解釋上面所描述的變化背后極其復雜的相關原因,并展示各種不同的影響因素。然而,我們應該首先注意到,這些類型的表面改變通常是幾個不同因素造成的結果,這些因素甚至可以根據個別場景相互作用和/或相互惡化。
        在分析與不銹鋼表面不常見的沉積物有關的變色問題背后的原因時(這在單個的韌性方面差別很大),通常的反應是首先聯系以下一個或多個組織:建造服務商、WD制造商和所使用的工藝化學品的供應商。
        上述每個接觸點從其自身的主觀角度選擇性地處理不銹鋼表面上的變色/(不希望的)膜的問題,然后可以回答其系統或產品正在完美地運行,并且不承擔造成變色的責任。從操作人員的角度來看,這種處理方法通常對需要進行的問題分析沒有幫助,也不有利于有效地解決問題。
        在分析根本原因時,需要首先檢查供應給設備的水的質量,以及從滅菌蒸汽中產生的凝析水的組成。
        此外,建議一個專家對從受影響的不銹鋼表面的變色中提取的拭子/磨損樣品進行化學物理分析。對這一分析結果的解釋將得出關于薄層的來源和原因的初步結論。
        然而,所有必要的介質供應參數即使符合,永久的薄膜/變色也完全有可能出現在滅菌器室的內表面。
        這本手冊提供了關于表面變色的潛在原因的基本和補充的提示和信息,以及處理這些典型的麻煩現象的建議。
        文本隨附的插圖和數據有助于確保涵蓋問題的整個范圍,包括所有相關因素。已經特別標注解釋蒸汽滅菌的主題,以及在這種背景下如何發生變色的潛在原因。
      在這個連接處,應當注意的是,這種被稱為均勻腐蝕的形式,這些不銹鋼表面的薄膜/變色也可以由除了本手冊中描述的造成紅銹以外許多其他極其多樣化的影響因素引起。例如,無腐蝕性不銹鋼合金表面的變色和與腐蝕相關的變化可能有以下已知的原因:

      ?水或蒸汽的質量不夠好   

      ?腔室表面沒有按照正確制造、和/或按照相同標準的材料

      ?合金質量不好

      ?制造腔室使用了不適合的制造技術

      ?滅菌材料中使用了不合適的物質

      ?被引入或帶入化學物質進入了腔室

      ?不銹鋼表面工作的不當方法的應用

      ?對腔室和裝載推車的化學攻擊,例如:不適合清潔的化學物質

      ?化學指示物或貼紙

      ?造成腐蝕風險的二級工藝(例如:磨擦腐蝕、點蝕、接觸腐蝕等)

      在每一種特定的情況下,其他因素也可能作為一個潛在的原因加以考慮。

      Introduction

        When medical instruments are reprocessed, they are sterilized in steam sterilizers that have been specially optimised for the task at hand. As a concept that has been known about for years, steam sterilization is a well researched and reliable processing method. For the technical design of the chambers, high-alloyed austenitic stainless steel alloys, such as 1.4301, 1.4404, 1.4571, and other similar alloys, are used as structural materials. Figures 1 and 2 show examples of a typical steam sterilizer, with a view of the sterilization chamber interior.
        In many application cases, actual operating experience has shown that, over the course of the sterilization chamber's service life, undesired discolouration often appears on the initially bright finish of the stainless steel surfaces in the chamber's interior regions. These types of changes in supposedly rustresistant stainless steel surfaces (see Figure 2) are often disconcerting to the employees in charge of the MPPU/CSSD (medical products processing unit / central sterile services department) and to those responsible for instrument processing.
        The goal of this guide is to provide an in- depth explanation of the, in some cases, extremely complex interrelated causes behind the changes described above, and to also present various different influencing factors. However, we should start by noting that these type of surface alterations are typically the result of several different factors that can even interact with and/or exacerbate one another depending on the individual scenario.
        The usual response when analysing the causes behind the discolouration problems (which vary greatly in terms of individual tenacity) found in connection with the typically unfamiliar deposits on stainless steel surfaces is to first contact one or more of the following groups: building services, the manufacturer of the WD and the suppliers of the process chemicals used.
        Each of the aforementioned points of contact approaches the issue of discolouration / (undesired) film on the stainless steel surfaces selectively, from its own individual, subjective perspective, and may then reply that its system or product is working flawlessly, and is therefore not responsible for causing the discolourations. From an operator's point of view, this approach is usually not very helpful for the problem analysis that needs to be performed, nor is it conducive to effectively resolving the problem.
        When analysing the root cause, it is important to first check the quality of the water being supplied to the devices, as well as the composition of the condensate from the sterilizing steam.
        In addition, a chemical-physical analysis of swab/abrasion samples taken by a specialist from the discolourations on the affected stainless steel surfaces is recommended. The interpretation of the results from this analysis will allow initial conclusions to be drawn about the sources and causes of the film. 
        However, it is entirely possible that, even if all of the necessary media-supply parameters are complied with, permanent films/ discolourations can appear on the interior surfaces of sterilizer chambers.
        This brochure provides basic and supplementary tips and information about the potential causes of surface discolourations, as well as recommendations for dealing these typically bothersome phenomena.
        The illustrations and figures accompanying the text help to ensure that the entire scope of the problem, including all of the related factors, is covered. Particular attention has been given to explaining the topic of steam sterilization and how potential causes of dis- colouration can occur in this context.
        At this junction it should be noted that, as what is referred to as form of uniform corrosion, these films/discolourations on stainless steel surfaces can also be caused by a host of other extremely diverse influencing factors aside from the rouging effect described in this brochure. Discolourations and corrosion-related alterations in the surface of noncorrosive stainless steel alloys can, for example, have the following known causes:

      ? Inadequate quality of water or steam

      ?Chamber surfaces that were not manufactured properly and/or in conformity with standards

      ? Unsatisfactory alloy quality

      ? Application of unsuitable methods for working stainless steel surfaces

      ? Unsuitable manufacturing techniques used in producing the chamber

      ? Unsuitable substances in the sterilization materials

      ? Introduction or carry-over of chemicals into the chamber

      ? Chemical indicators or stickers

      ? Chemical attacks on the chamber or loading trolleys, e.g. through the use of chemicals not suitable for cleaning

      ? Secondary processes posing corrosion risks (e.g. fretting corrosion, pitting,contact corrosion, etc.)

      In each specific case, other factors may also come into consideration as a potential cause.



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